BEUDAMED
    FDA Enforcement Class II Ongoing

    Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE UTILITY SHEARS (USH176), Product Code 67225; f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670

    Recall: Z-1449-2024 · Reported April 10, 2024

    Enforcement

    Recall Number
    Z-1449-2024
    Event ID
    94136
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 10, 2024
    Initiation Date
    February 23, 2024
    Classification Date
    March 29, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE UTILITY SHEARS (USH176), Product Code 67225; f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670

    Reason

    Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

    Code Info

    a) 65140, UDI/DI 60653160008380 (case) 00653160008388 (each), Lot Numbers: 2023060790, 2023101090; b) 65840, UDI/DI 60653160010208 (case) 00653160010206 (each), Lot Numbers: 2023022790, 2023041190; c) 66240, UDI/DI 60653160008793 (case) 00653160008791 (each), Lot Numbers: 2023112790; d) 66855, UDI/DI 50653160007188 (case) 00653160007183 (each), Lot Numbers: 2023022490, 2023041990, 2023102690; e) 67225, UDI/DI 50653160001766 (case) 00653160001761 (each), Lot Numbers: 2023031690, 2023111490; f) TRI66670, UDI/DI 10653160317975 (case) 20653160317972 (each), Lot Numbers: 2023031490, 2023040690, 2023041090, 2023062790, 2023062890, 2023072490, 2023101690, 2023110190, 2023110990

    Distribution

    Worldwide distribution - US Nationwide and the countries of Panama, Canada.

    Quantity

    84224 units